以下是醫(yī)療器械歐盟認(rèn)證標(biāo)準(zhǔn)一覽表：

所有的醫(yī)用電氣設(shè)備:

- IEC/EN60601-1 2nd Ed,

- IEC/EN60601-1 3rd Ed

體外診斷設(shè)備:

- 體外診斷設(shè)備 In vitro diagnostic (IVD) equipment

- IEC/EN61010-1,

- IEC/EN61010-2-101

醫(yī)用電氣系統(tǒng) Medical electrical systems:

- IEC/EN60601-1-1

警報(bào)系統(tǒng) alarm systems in medical electrical equipment and medical electrical systems:

- IEC/EN60601-1-8

高頻手術(shù)設(shè)備:

- High frequency surgical equipment

- IEC/EN60601-2-2

神經(jīng)和肌肉刺激器:

- Neuromuscular Stimulation Device

- IEC/EN60601-2-10

麻醉系統(tǒng):

- Anaesthetic systems

- IEC/EN60601-2-13

內(nèi)窺鏡:

- Endoscopic equipment

- IEC/EN60601-2-18

心電圖機(jī):

- Electrocardiographs

- IEC/EN/UL 60601-1,

- IEC/EN60601-2-25,

- IEC/EN60601-2-51

無(wú)創(chuàng)血壓監(jiān)護(hù):

- Automated non-invasive sphygmomanometers

- IEC/EN60601-2-30

醫(yī)用電熱毯，褥和墊 Blankets, pads and mattresses, intended for heating in medical use:

- IEC/EN60601-2-35

診斷超聲設(shè)備:

- Diagnostic Ultrasonic Device

- IEC/EN 60601-1,

- IEC/EN60601-2-37

治療超聲設(shè)備:

- Therapeutic Ultrasonic Device

- IEC/EN 60601-1,

- EN60601-2-5

醫(yī)院電動(dòng)床:

- Hospital Electric Bed

- IEC/EN60601-2-38,

- IEC/EN60601-2-52

流動(dòng)心電圖機(jī):

- Ambulatory electrocardiographic systems

- IEC/EN60601-2-47,EC38

多功能病人監(jiān)護(hù)儀:

- Multifunction Patient Monitor

- IEC/EN/UL60601-1,

- IEC/EN60601-2-27,

- IEC/EN60601-2-30,

- IEC/EN60601-2-34,

- IEC/EN60601-2-49,

- ISO9919,EN12470-4

電子血壓計(jì):

- Sphygmomanometer

- EN1060-1,EN1060-3,SP10

輪椅/電動(dòng)代步車:

- Wheelchairs/Electric Scooters

- ISO7176 Serial,

- EN12183,EN12184,

- GB18029 Serial

拐杖/助行器:

- Walking Sticks/Walking Aids

- ISO11199 Serial,

- ISO11334 Serial,

- EN1985,BS5205,

- BS497,BS5181,

- JIST9204

洗澡椅/便器椅:

- Shower Chairs/Sanitary Chairs

- BSEN12182,AS3973

殘疾人輔助器具:

- Technical Aids for Disabled Persons

- BSEN12182

60601-2-40